K850146 is an FDA 510(k) clearance for the SIREDOC, PAPER CHART RECORDER. This device is classified as a Recorder, Paper Chart (Class I - General Controls, product code DSF).
Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on February 12, 1985, 29 days after receiving the submission on January 14, 1985.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2810.
| 510(k) Number | K850146 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 14, 1985 |
| Decision Date | February 12, 1985 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DSF — Recorder, Paper Chart |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 870.2810 |